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On Monday, Apogee Therapeutics, Inc. (NASDAQ:APGE) released interim Phase 1 results from its first-in-human trial of APG990.
APG990 interim Phase 1 pharmacokinetic (PK) data showed a half-life of approximately 60 days across doses tested.
Key data from the 40-healthy subject trial showed:
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APG990 demonstrated a potential best-in-class PK profile, including a half-life of approximately 60 days, supporting the potential for every three- and six-month maintenance dosing. The PK profile supports the potential for a single 2 mL co-formulated injection of APG279 (APG777 + APG990) administered every three and six months.
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APG990 was well tolerated across all five cohorts, with doses up to 1,200mg. The most common (≥10%) treatment-emergent adverse events (TEAEs) were headache.53% of participants observed at least one TEAE.
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There were no Grade 3 TEAEs related to the study drug or severe adverse events. No adverse events led to study discontinuation. There have been no cases of pyrexia or chills.
In addition, preclinical studies of the combination of APG777 and APG990 showed potential for enhanced pharmacologic responses relative to individual agents and exhibited no safety findings at any dose level, including the highest dose tested of 150 mg/kg per agent in a 3-month combination toxicology study.
The company plans to submit an Investigational New Drug application or foreign equivalent for APG279.
Following clearance, the company plans to initiate a Phase 1b clinical trial in moderate-to-severe atopic dermatitis (AD) of APG279 against Sanofi SA (NASDAQ:SNY) / Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Dupixent (dupilumab) in 2025, with data expected in the second half of 2026.
The company says cash, cash equivalents, and marketable securities were $731.1 million as of December 31, 2024. Based on current operating plans, Apogee expects its existing cash, cash equivalents, and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028.
Price Action: APGE stock is up 7.14% at $33.68 at the last check Monday.
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This article Apogee Therapeutics' Investigational Atopic Dermatitis Potential Shows Strong Tolerability, Extended Half-Life in Early Trial originally appeared on Benzinga.com
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